This invention relates to medical tube holders of a type which is attached to the outer surface of a patient's body.
In a number of hospital and homecare settings, the ability to securely attach one or a variety of medical tubes to the body of a patient is important in facilitating medical care. Any device which is to be used for such a purpose should satisfy a number of requirements--it should maintain the medical tube in its proper position on the patient's body despite movement by the patient; it should be convenient for the nurse or practitioner to use, allowing them to install, adjust or relocate the medical tube periodically as required, preferably without the need to adjust tape or loosen sutures; and it must be as comfortable as possible for the patient.
The simplest and most common method of attaching medical tubes to the body of a patient involves the use of adhesive tape as a means of anchoring the tube in position. The disadvantages of using adhesive tape are numerous--they include the need to apply a substantial adhesive area to the patient's skin and, at the same time, to apply the same adhesive material to the relatively small area of a slippery tube material thereby necessitating use of a potential irritant to the skin; the need for constant surveillance to monitor loss of adhesiveness; the likelihood of patient discomfort; and the increased risk of infection.
Such disadvantages have led to proposals for a number of medical tube holders of varying design. One limitation of the medical tube holders developed to date has been the degree of manual dexterity and skill required for the attachment procedure.
The Quickstrap device is an endotracheal tube holder, manufactured by IPI Medical Products of Chicago, Ill. It consists of a bite block and a non-elastic neckstrap. The neckstrap is designed so that it can be secured on a patient's head without the use of adhesive tape. The bite block is composed of a flexible, plastic-like material and fits within the neckstrap. It is the part of the device which actually holds the endotracheal tube in place. The bite block consists of two continuous regions--a U-shaped channel region, situated nearest the patient, through which the endotracheal tube is guided into the patient's mouth; and a securing region, which is essentially a notched strap with a Y-shaped rectangular metal hinge structure inserted into its middle portion.
When positioned within the Quickstrap device, the endotracheal tube lies along the longitudinal axis of the bite block. It touches the two sides of the metal hinge structure. Each side of the metal hinge structure contains five raised, rounded, abrasive metal heads in a horizontal array. Each head contacts the outer surface of the endotracheal tube when it is secured within the bite block by the tightening and securing of the strap within the neck support.
The number of potential applications of the Quickstrap device is limited in that it can only be used for placement of endotracheal tubes. In addition, its design makes it unsuitable for scaling down to the size that would be required for its use in the young child and infant patient populations. It also suffers from a number of significant other disadvantages. The neckstrap is cumbersome, covering an extensive area of the patients head and requiring considerable manipulation of the patient for its placement. The design of the neckstrap is such that it could also cause the patient a considerable degree of discomfort; the plastic straps of the bite block are difficult to secure; the use of notches of fixed position for securing the strap makes placement of the endotracheal tube difficult, especially when the circumference of the endotracheal tube does not exactly match the position of the notch. In addition, application of a force greater than that required for secure placement could be necessitated by the arrangement of the notches and could lead to undesireable constriction of the tube; the use of an elasticated strap to compress the abrasive heads of the hinge structure as a means of securing the PVC endotracheal tube leads to progressive constriction if over tightened, a result of continuing forces from the elasticated band itself, tube warming and the pliable characteristics of the PVC tube.
A medical tube holder designed for use with infants is disclosed in U.S. Pat. No. 4,906,234 issued Mar. 6, 1990 to Thomasz H. Voychehovski. The '234 patent describes a device suitable for the secure placement of a medical tube such as an endotracheal tube in an infant. The device of the '234 patent consists of a band, extending across the full width of the infant's face, which is attached by three adhesive pads to the skin. A series of receptacles positioned at regular intervals along the band are each capable of receiving an anchor element. Each anchor element, consisting of a plug and collar, is the part of the device which actually holds the medical tube securely in place. The numerous receptacles situated along the length of the band only allow medical tubes to be placed at predetermined positions and, at the same time, unecessarily complicate the device.
An endotracheal tube holder designed for use with infants is disclosed in U.S. Pat. No. 4,683,882 issued Aug. 4, 1987 to Jesse S. Laird. The device of the '882 patent consists of a base portion which is attached to the infant's face by an adhesive strap and a clamp which is supported on the base portion. The clamp can be one of three types of design--a gate-type clamp, in which the rotary movement of a thumbscrew causes a clamp member to move in a linear direction thereby locking the medical tube against the base portion; a C-clamp, in which the turn of a thumbscrew either loosens or tightens the clamp about the tube; or a clamp consisting of a strap connected to a clamp-base element. The latter type of clamp design is discussed in more detail below.
The devices of the '234 and '882 patents suffer from significant disadvantages, especially when they are used in the young child or infant patient populations. The clamp type embodiments are unsuitable for many medical applications since they require one end of the tube to be threaded through the device in order to be clamped. Such a procedure is often impossible and always undesirable. The mechanisms of using a thumb screw to clamp the tube may be hazardous when the thumb screw length-of-travel allows the user to inadvertently obstruct the flow of fluid through the tube. If a limitation on the thumb screw length-of-travel is introduced into the design in order to avoid obstruction of the tube, the device becomes tube size specific. Such size specificity would limit the device's general application and so would be an undesirable feature. In addition, external forces exerted on the tube can be transmitted to the surface of the patient's skin. The devices do not contain means of strain relief to reduce skin damage and/or tube kinking.
The device of U.S. Pat. No. 4,392,857 issued on Jul. 12, 1983 to Anthony V. Beran discloses a tube holder which includes a clamp comprising a clamp base and a wrap-around strap. At least one side of the wrap-around strap and one arm of the clamp base contain complementarily-formed triangular slots. The interlocking nature of the complementary slots situated on the clamp base and wrap-around strap act as the primary means of securing the medical tube within the tube holder.
The clamp of the '857 patent is deficient in that, even when used in an adult patient population, it requires an operator to use a high degree of manual dexterity in a movement which often leaves the medical tube free to move in an uncontrolled manner when the clamp is being engaged around it. In addition, once secured within the clamp it is difficult to disengage the medical tube. These disadvantages act to increase patient discomfort and become significant limitations on use of the clamp, especially once reduced to the scale required for use in the young child and infant patient populations.
One embodiment of the '882 patent discussed earlier, describes a clamp consisting of a strap with a notched end which is secured within a keeper element. The strap wraps around the medical tube and the notched end is placed within the keeper element. The medical tube is then secured within the clamp by pulling the strap through the keeper element until it is taut.
The clamp described in this embodiment of the '882 patent is an improvement over that described in the '857 patent in as much as it allows the medical tube to be more easily disengaged. However, the clamp of the '882 patent is rigid and requires a strong gripping action and significant manual dexterity on the part of the operator. Moreover, another significant disadvantage shared by both clamps arises from the use of notches of fixed position as the primary means of securing a medical tube. As discussed earlier with use of the Quickstrap device, none of the fixed positions may correspond exactly to the diameter of a specific medical tube thus necessitating the application of force by the operator and ultimately constriction of the medical tube in order to obtain its secure placement within the clamp. The application of force, especially by those unskilled in using the device, may lead to patient discomfort and movement of the medical tube within the patient's body. More seriously, the constriction of the medical tube may, in some instances, be dangerous to the patient's health and general well being. The '882 patent does not describe any means of strain relief between the point where the tube is clamped and its point if contact with the patient's skin.
In today's healthcare climate with its emphasis on homecare and other alternatives to prolonged hospitalization, the availability of a simple, effective means of securing a medical tube to a patient's body which is capable of being readily utilized by the skilled and unskilled alike, is highly desirable.
The present invention contemplates provision of an inexpensive, easy to apply means of securing a medical tube to a patient's body. The manner in which this has been achieved is by the design of a clamp which secures a medical tube by means of a wrap-around non-elastic strap. Due to its unitary construction and the simplicity associated with its use, the present invention is particularly suited to applications involving young children and infants aswell as to those applications where medical tubing needs to be safely secured while still allowing easy release and re-securing for body depth tube adjustments.